Interventions for valvular disease and heart failure

Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation

EuroIntervention 2023;19:580-588. DOI: 10.4244/EIJ-D-23-00344

Juan Pablo Sanchez-Luna
Juan Pablo Sanchez-Luna1, MD; Pedro Martín2, MD; Antonio E. Dager3, MD; Pablo D. Charry4, MD; Javier R. Beltrán5, MD; Ángel Sánchez-Recalde6, MD; Francesco Giannini7, MD; Antonio Gómez-Menchero8, MD; Manuel Pan9, MD; Alfonso Ielasi10, MD; Andrea Monastyrski11, MD; Marco Barbanti12, MD; Francisco Fernandez-Avilés13, MD, PhD; Marco Bruno Ancona7, MD; Abdurashid Mussayev14, MD; Juan Pablo De Brahi15, MD; Pablo Lamelas16, MD; Andrés Sánchez-Pérez2, MD; Melissa García Puerta3, MD; Miguel Ortiz3, MD; Jose Carlos Gonzalez-Gutiérrez1, MD; Giorgio Marengo1, MD; Javier Gómez1, MD; Esther Gonzalez-Bartol1, MD; Alexander Stepanenko1, MD; Itziar Gomez-Salvador17, MSc; J. Alberto San Román1,17, MD, PhD; Ignacio J. Amat-Santos1,17, MD, PhD
1. Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain; 2. Cardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, Spain; 3. Cardiology Department, Angiografía de Occidente Hospital, Cali, Colombia; 4. Cardiology Department, Clínica Medilaser, Neiva, Colombia; 5. Cardiology Department, Los Comuneros Hospital Universitario de Bucaramanga, Bucaramanga, Colombia; 6. Cardiology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain; 7. Cardiology Department, San Raffaele Scientific Institute, Milan, Italy; 8. Cardiology Department, Hospital Juan Ramón Jimenez, Huelva, Spain; 9. Cardiology Department, Hospital Reina Sofía, Cordoba, Spain and University of Cordoba (IMIBIC), Cordoba, Spain; 10. Cardiology Department, IRCCS Ospedale Galeazzi Sant’Ambrogio, Milan, Italy; 11. Cardiology Department, Hospital Universitario Val d’Hebron, Barcelona, Spain; 12. Cardiology Department, Policlinico-Vittorio Emanuele Hospital, Catania, Italy; 13. Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; 14. Cardiology Department, National Research Cardiac Surgery Center, Astana, Kazakhstan; 15. Cardiology Department, Sanatorio de La Trinidad Mitre, Buenos Aires, Argentina; 16. Cardiology Department, Instituto Cardiovascular, Buenos Aires, Argentina; 17. Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Madrid, Spain

Background: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting.

Aims: We aimed to evaluate the safety and feasibility of Myval in NCAR.

Methods: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed.

Results: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047).

Conclusions: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

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aortic regurgitationballoon-expandable valvetavrtranscatheter valve implantationvalve disease
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